Back to resultsA Treatment-Option Protocol to Provide Brentuximab Vedotin to Eligible Patients Completing Studies SGN35-005 or C25001
Primary Purpose
Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin
Status
No longer available
Phase
Locations
International
Study Type
Expanded Access
Intervention
brentuximab vedotin
Sponsored by
About this trial
This is an expanded access trial for Disease, Hodgkin focused on measuring Disease, Hodgkin, Lymphoma, Monomethylauristatin E, Lymphoma, Large-Cell, Anaplastic, Lymphoma, T-Cell, Cutaneous, Lymphoma, Non-Hodgkin, Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD30, Hematologic Diseases, Immunotherapy
Eligibility Criteria
Inclusion Criteria:
- Participated in either the SGN35-005 or C25001 clinical study and experienced progression. Patients who received brentuximab vedotin in C25001 must have had an objective response at the time of discontinuation.
- Completed any previous treatment with radiation, chemotherapy, biologics and/or investigational agents at least 4 weeks prior to the first dose of brentuximab vedotin
Exclusion Criteria:
- History of another primary malignancy that has not been in remission for at least 3 years
- Known cerebral/meningeal disease
- Peripheral neuropathy of grade 2 or greater
- Females who are pregnant or breastfeeding
Sites / Locations
- Stanford Cancer Center
- Dana-Farber Cancer Institute
- MD Anderson Cancer Center / University of Texas
- Peter MacCallum Cancer Center
- Leuven University Hospital
- Specializirana bolnica aktivno lechenie detsa ohcohematologichni zabolyavania Hematologichno
- Specializirana bolnica za aktivno lechenie na hematologichni zabolyavania
- Hopital Saint-Louis/Service d'Hematologie
- South Lyon Hospital Center, Department of Dermatology
- Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer
- Johannes Wesling Hospital Minden, Department of Dermatology
- Szent Istvan es Szent Laszlo Korhaz Rendelointezet Haematologiai es Ossejt-transzplantacios osztaly
- Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika
- Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont
- Polyclinic S. Orsola-Malpighi, Institute of Hematology and Medical Oncology "Lorenzo and Ariosto Seragnoli"
- IRCCS University Hospital San Martino
- Klinika Hematologii, Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
- Klinika Hematologii, Instytut Hematologii i Transfuzjologii
- Centrum Onkologii Institut im. Marii Sklodowskiej-Curie
- Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular
- Fundeni Clinical Institute, Center for Hematology and Bone Marrow Transplantation
- Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu
- Rossijskij onkologicheskij nauchnyj centr im. N.N. Blokhina RAMN
- Gematologicheskj nauchnyj centr RAMN
- Research Institute of Clinical Immunology
- Sankt-Peterburgskij gosudarstvennyj medicinskij universitet im. akademika I. P. Pavlova
- Clinical Center of Serbia, Clinic of Hematology
- University Hospital 12 de Octubre, Department of Dermatology
- University Hospital Zurich, Department of Dermatology
- Queen Elizabeth Hospital
- St John's Institute of Dermatology
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01196208
First Posted
September 3, 2010
Last Updated
September 17, 2020
Sponsor
Seagen Inc.
Collaborators
Millennium Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01196208
Brief Title
A Treatment-Option Protocol to Provide Brentuximab Vedotin to Eligible Patients Completing Studies SGN35-005 or C25001
Official Title
An Open-label, Treatment-option Protocol of Brentuximab Vedotin in Patients With Relapsed or Refractory Hodgkin Lymphoma, Systemic Anaplastic Large Cell Lymphoma, or CD30-positive Cutaneous T-cell Lymphoma
Study Type
Expanded Access
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seagen Inc.
Collaborators
Millennium Pharmaceuticals, Inc.
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to provide the option of brentuximab vedotin treatment to eligible patients in studies SGN35-005 and C25001
Detailed Description
The protocol was amended to reflect the change from a phase 2/3 to a study with an expanded access program (EAP) in the US that would include patients with ALCL and HL. A later amendment allowed patients with CD30-positive cutaneous T-cell lymphoma to enroll. Enrollment may continue and patients may receive brentuximab vedotin treatment on study until the drug is commercially approved and available to patients in a geographic region.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin, Lymphoma, T-Cell, Cutaneous
Keywords
Disease, Hodgkin, Lymphoma, Monomethylauristatin E, Lymphoma, Large-Cell, Anaplastic, Lymphoma, T-Cell, Cutaneous, Lymphoma, Non-Hodgkin, Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD30, Hematologic Diseases, Immunotherapy
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
brentuximab vedotin
Other Intervention Name(s)
SGN-35
Intervention Description
Every 21 days by intravenous infusion (1.8 mg/kg)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participated in either the SGN35-005 or C25001 clinical study and experienced progression. Patients who received brentuximab vedotin in C25001 must have had an objective response at the time of discontinuation.
Completed any previous treatment with radiation, chemotherapy, biologics and/or investigational agents at least 4 weeks prior to the first dose of brentuximab vedotin
Exclusion Criteria:
History of another primary malignancy that has not been in remission for at least 3 years
Known cerebral/meningeal disease
Peripheral neuropathy of grade 2 or greater
Females who are pregnant or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liga Ulmane, MD
Organizational Affiliation
PSI Company Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Stanford Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
MD Anderson Cancer Center / University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4003
Country
United States
Facility Name
Peter MacCallum Cancer Center
City
Melbourne
ZIP/Postal Code
3002
Country
Australia
Facility Name
Leuven University Hospital
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Specializirana bolnica aktivno lechenie detsa ohcohematologichni zabolyavania Hematologichno
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
Specializirana bolnica za aktivno lechenie na hematologichni zabolyavania
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
Hopital Saint-Louis/Service d'Hematologie
City
Paris
State/Province
Cedex 10
ZIP/Postal Code
75475
Country
France
Facility Name
South Lyon Hospital Center, Department of Dermatology
City
Lyon
ZIP/Postal Code
69495
Country
France
Facility Name
Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Johannes Wesling Hospital Minden, Department of Dermatology
City
Minden
ZIP/Postal Code
32429
Country
Germany
Facility Name
Szent Istvan es Szent Laszlo Korhaz Rendelointezet Haematologiai es Ossejt-transzplantacios osztaly
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika
City
Debrecen
ZIP/Postal Code
4004
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Polyclinic S. Orsola-Malpighi, Institute of Hematology and Medical Oncology "Lorenzo and Ariosto Seragnoli"
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
IRCCS University Hospital San Martino
City
Genoa
ZIP/Postal Code
16132
Country
Italy
Facility Name
Klinika Hematologii, Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
City
Lodz
ZIP/Postal Code
93-510
Country
Poland
Facility Name
Klinika Hematologii, Instytut Hematologii i Transfuzjologii
City
Warsaw
ZIP/Postal Code
02-766
Country
Poland
Facility Name
Centrum Onkologii Institut im. Marii Sklodowskiej-Curie
City
Warsaw
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular
City
Targu Mures
State/Province
Judetul Mures
ZIP/Postal Code
540136
Country
Romania
Facility Name
Fundeni Clinical Institute, Center for Hematology and Bone Marrow Transplantation
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Rossijskij onkologicheskij nauchnyj centr im. N.N. Blokhina RAMN
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Gematologicheskj nauchnyj centr RAMN
City
Moscow
ZIP/Postal Code
125167
Country
Russian Federation
Facility Name
Research Institute of Clinical Immunology
City
Novosibirsk
ZIP/Postal Code
630099
Country
Russian Federation
Facility Name
Sankt-Peterburgskij gosudarstvennyj medicinskij universitet im. akademika I. P. Pavlova
City
St. Petersburg
ZIP/Postal Code
197101
Country
Russian Federation
Facility Name
Clinical Center of Serbia, Clinic of Hematology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
University Hospital 12 de Octubre, Department of Dermatology
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
University Hospital Zurich, Department of Dermatology
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Queen Elizabeth Hospital
City
Birmingham
Country
United Kingdom
Facility Name
St John's Institute of Dermatology
City
London
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Treatment-Option Protocol to Provide Brentuximab Vedotin to Eligible Patients Completing Studies SGN35-005 or C25001
We'll reach out to this number within 24 hrs